Status and phase
Conditions
Treatments
About
This was a randomized, multi-center, partially placebo-controlled Phase IV study to compare the efficacy and tolerability of a 48-week combined therapy with pegylated interferon alpha-2a, ribavirin and amantadine sulphate versus placebo in untreated patients with chronic hepatitis C virus-genotype-1-infection. The hypothesis was that there will be an increase in sustained response rate for triple therapy compared to current standard treatment.
Full description
Primary Objective:
Secondary Objectives:
Sex
Ages
Volunteers
Inclusion criteria
If one or more of the above inclusion criteria are not fulfilled, the patient is excluded from the study!
Exclusion criteria
Any known sensitive reaction to interferon, ribavirin or amantadine sulphate.
Pregnant or breast-feeding women and fertile women who do not practice contraception.
Male partners of pregnant women.
Previous treatment with interferon and/or ribavirin.
Treatment with systemic anti-neoplastic or immunomodulatory medication (supraphysiologic doses of steroids or radiation included) within the last 6 months prior to the study and throughout the whole study.
Immunosuppressed/immunocompromised patients.
Participation in a clinical study within the last three months.
Infection with HCV genotype-2, -3, -4, -5 or -6.
Positive indication of HBsAg, HIV antibodies in the screening phase.
Non-hepatitis C virus-induced chronic hepatitis (e.g. hematochromatosis, autoimmune hepatitis, metabolic or alcoholic liver disease).
Decompensated liver cirrhosis or liver disease; Child-Pugh Grade B or C; or threshold compensated liver disease.
Signs of a hepatocellular carcinoma within 2 months before the randomization, coupled with existing or developing cirrhosis.
History of oesophagus varices haemorrhage.
Hemoglobin <12 g/dl in female subjects and <13 g/dl in male subjects in the screening phase.
Subjects with a higher risk of anemia (e.g. thalassemia, spherocytosis, history of gastrointestinal bleeding) or subjects for whom anemia could be a highly potential medical risk.
Neutropenia <1500 /µl or thrombocytopenia <90,000 /µl diagnosed in the screening phase.
Serum creatinine >1.5 mg/dl in the screening phase.
History of severe psychiatric diseases, especially severe depression, whereby severe psychiatric disease is defined as any anti-depressive or anti-psychotic therapy of at least 3 months in the history, or any indication of suicidal inclination or hospitalization caused by a psychiatric disease.
Epilepsy.
Autoimmune disease (e.g. inflammatory intestinal diseases, idiopathic thrombocytopenic purpura, lupus erythematosus sclerodermia, severe psoriasis, rheumatoid arthritis, etc.).
History of thyroid disease, poorly controlled by prescribed medications
Chronic pulmonary disease with functional restriction.
History of severe cardiac disease, e.g. cardiac insufficiency New York Heart Association (NYHA) class III or IV; myocardial infarction within the last 6 months; ventricular tachyarrhythmia requiring treatment; unstable angina pectoris; cerebrovascular circulation disorders; or other significant cardiovascular diseases.
Patients with pacemakers.
Cardiomyopathy and myocarditis
Atrioventricular (AV)-block Grade II and III.
Previously known bradycardia rating under 55 strokes/minute
Known, lengthy QT-interval (QTc as per Bazett > 420 ms) or recognizable U waves or hereditary QT-syndrome in the family history.
History of a severe ventricular arrythmia including Torsade de pointes.
Simultaneous therapy with budipine or other QT-extending medication such as:
Morbus Parkinson.
History of major organ transplantations, with the exception of cornea transplantation.
Cancer or any other disease, which, in the opinion of the investigator, is an exclusion criterion for the study.
Evidence of severe retinopathy (e.g. cytomegalovirus [CMV] retinitis or macular degeneration).
Patients with narrow-angle glaucoma.
Active drug abuse (excessive alcohol consumption included) within the last year prior to study (with the exception of a prescribed substitute).
Patients with state of agitation or confusion
Patients with a history of acute brain syndrome or exogenous psychosis
Patients are already enrolled in the study.
Prostate hypertrophy
Simultaneous administering of diuretics of combination type triamterene/hydrochlorothiazide.
Unwillingness or incapability to give written consent after receiving medical information; doubts about the proper protection of patient data; and general reluctance to take part in the study and to adhere to the study terms.
If one or more of these exclusion criteria is fulfilled, the patient shall be excluded from the study!
Primary purpose
Allocation
Interventional model
Masking
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal